''A Phase III, multicenter, open-label study, to evaluate the efficacy and safety of different dosage regimens of 0.2 mg lofexidine hydrochloride (DIMATEX) in the treatment of withdrawal symptoms during opioid detoxification''

GET SR0 个研究点开始时间: 2011年12月22日最近更新: 2015年10月12日

适应症

试验速览

暂无简介。

•a)Mail and femal between 18 and 60 years. b)Subjects addicted from heroin follwing DSM-IV criteria, whom have already been decided the inclusion in a fast detoxification program or Subjects addicted from heroin following DSM IV criteria treated with methadone maintenance treatement(< 40 mg/die) o buprenorphine (< 8 mg/die) o buprenorphine/naloxone (< 8 mg/die)undergoing a drug free detoxification process from heroin, methadone, buprenorphine and buprenprphine/naloxone. c) Subjects with positive urine test for heroin and syntesis opiate (methadone, buprenorphine) and negative for other drugs. d) Subjects with laboratory results that must have non clinical significant results that could interfire with the study conduction and evaluation. e) Subjects able to understand and sign the Informed Consent form.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•a)Subjects with blood pressure < 90/60 mm/Hg and/or in treatement with hypotensive drug. b)Subsects with heart insufficiency(NYHA, classe II)or resting heart frequency < 55 bpm or severe cardiac disorders during anamnesis. c)Subjects with diabetes mellitus. d)Subjects with significant liver disease (AST and/or ALT > 3N). e) Subjects positiv to HBV and /or HCV in pharmacological treatment. f)Subjects with gastric disease that could change the absorption of study drug. g)Subjects with asthma in chronic treatment. h) Subjects with severe psychiatric disorders including psychosis, bipolar disorder, schizophrenia, depression. j)Epileptics or subjects that have been treated with anticonvulsants in the last 3 years. k)Non-compliance during the study, in accordance with the Investigator opinion.

发起方

GET SR